GASTROTONE- capsicum annuum, foeniculum vulgare, symphytum officinale, argentum nitricum, arsenicum album, magnesia phosphorica, pulsatilla (vulgaris) liquid 
BioActive Nutritional, Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Drug Facts:

ACTIVE INGREDIENTS:

Capsicum Annuum 3X, Foeniculum Vulgare 3X, Symphytum Officinale 3X, Argentum Nitricum 12X, Arsenicum Album 12X, Magnesia Phosphorica 12X, Pulsatilla (Vulgaris) 12X.

INDICATIONS:

For temporary relief of indigestion, flatulence, nausea, retching, vomitting after eating or drinking; minor burning pain in the stomach, and stomach irritable.

WARNINGS:

If pregnant or breast-feeding, ask a health care professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Do not use if tamper evident seal is broken or missing.

Store in cool, dry place.

KEEP OUT OF REACH OF CHILDREN:

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

INDICATIONS:

For temporary relief of indigestion, flatulence, nausea, retching, vomitting after eating or drinking; minor burning pain in the stomach, and stomach irritable.

INACTIVE INGREDIENTS

Demineralized Water, 25% Ethanol.

QUESTIONS:

Distributed by:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com

PACKAGE LABEL DISPLAY:

BIOActive Nutritional

GASTROTONE

HOMEOPATHIC

1 FL OZ (30 ml)

Gastrotone

GASTROTONE 
capsicum annuum, foeniculum vulgare, symphytum officinale, argentum nitricum, arsenicum album, magnesia phosphorica, pulsatilla (vulgaris) liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43857-0458
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG) CAPSICUM3 [hp_X]  in 1 mL
FENNEL SEED (UNII: G3QC02NIE6) (FENNEL SEED - UNII:G3QC02NIE6) FENNEL SEED3 [hp_X]  in 1 mL
COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT6 [hp_X]  in 1 mL
SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A) SILVER NITRATE12 [hp_X]  in 1 mL
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE12 [hp_X]  in 1 mL
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE12 [hp_X]  in 1 mL
PULSATILLA VULGARIS (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) PULSATILLA VULGARIS12 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43857-0458-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product09/05/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic09/05/2017
Labeler - BioActive Nutritional, Inc. (624980496)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(43857-0458) , api manufacture(43857-0458) , label(43857-0458) , pack(43857-0458)

Revised: 9/2017
Document Id: a7ff4e0a-b652-4386-944d-558d47ab8641
Set id: 1ba810f2-ee90-400c-81d7-d066c5eebe59
Version: 1
Effective Time: 20170905
 
BioActive Nutritional, Inc.